title: A randomized controlled study of peanut oral immunotherapy: clinical desensitization and modulation of the allergic response.
abstract: BACKGROUND
  Open-label oral immunotherapy (OIT) protocols have been used to treat small numbers of patients with peanut allergy. Peanut OIT has not been evaluated in double-blind, placebo-controlled trials.
  
  
  OBJECTIVE
  To investigate the safety and effectiveness of OIT for peanut allergy in a double-blind, placebo-controlled study.
  
  
  METHODS
  In this multicenter study, children ages 1 to 16 years with peanut allergy received OIT with peanut flour or placebo. Initial escalation, build-up, and maintenance phases were followed by an oral food challenge (OFC) at approximately 1 year. Titrated skin prick tests (SPTs) and laboratory studies were performed at regular intervals.
  
  
  RESULTS
  Twenty-eight subjects were enrolled in the study. Three peanut OIT subjects withdrew early in the study because of allergic side effects. During the double-blind, placebo-controlled food challenge, all remaining peanut OIT subjects (n = 16) ingested the maximum cumulative dose of 5000 mg (approximately 20 peanuts), whereas placebo subjects (n = 9) ingested a median cumulative dose of 280 mg (range, 0-1900 mg; P < .001). In contrast with the placebo group, the peanut OIT group showed reductions in SPT size (P < .001), IL-5 (P = .01), and IL-13 (P = .02) and increases in peanut-specific IgG(4) (P < .001). Peanut OIT subjects had initial increases in peanut-specific IgE (P < .01) but did not show significant change from baseline by the time of OFC. The ratio of forkhead box protein 3 (FoxP3)(hi): FoxP3(intermediate) CD4+ CD25+ T cells increased at the time of OFC (P = .04) in peanut OIT subjects.
  
  
  CONCLUSIONS
  These results conclusively demonstrate that peanut OIT induces desensitization and concurrent immune modulation. The current study continues and is evaluating the hypothesis that peanut OIT causes long-term immune tolerance.
authors.affiliation: Department of Pediatrics, Division of Allergy and Immunology, Duke University Medical Center, Durham, NC, USA.
authors.forename: Pooja
authors.initials: P
authors.lastname: Varshney
authors.forename: Stacie M
authors.initials: SM
authors.lastname: Jones
authors.forename: Amy M
authors.initials: AM
authors.lastname: Scurlock
authors.forename: Tamara T
authors.initials: TT
authors.lastname: Perry
authors.forename: Alex
authors.initials: A
authors.lastname: Kemper
authors.forename: Pamela
authors.initials: P
authors.lastname: Steele
authors.forename: Anne
authors.initials: A
authors.lastname: Hiegel
authors.forename: Janet
authors.initials: J
authors.lastname: Kamilaris
authors.forename: Suzanne
authors.initials: S
authors.lastname: Carlisle
authors.forename: Xiaohong
authors.initials: X
authors.lastname: Yue
authors.forename: Mike
authors.initials: M
authors.lastname: Kulis
authors.forename: Laurent
authors.initials: L
authors.lastname: Pons
authors.forename: Brian
authors.initials: B
authors.lastname: Vickery
authors.forename: A Wesley
authors.initials: AW
authors.lastname: Burks
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D002648:Child; D002675:Child, Preschool; D003888:Desensitization, Immunologic; D005260:Female; D006801:Humans; D006967:Hypersensitivity / Q000276:immunology* / Q000628:therapy*; D007167:Immunotherapy; D007223:Infant; D008297:Male; D021183:Peanut Hypersensitivity / Q000276:immunology* / Q000628:therapy*